UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024840 |
|---|---|
| Receipt number | R000028586 |
| Scientific Title | Efficacy of Abdominal peripheral nerve block for Surgical space condition during robotic assisted laparoscopic surgery |
| Date of disclosure of the study information | 2017/02/01 |
| Last modified on | 2019/11/24 11:59:08 |
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Basic information
Public title
Efficacy of Abdominal peripheral nerve block for Surgical space condition during robotic assisted laparoscopic surgery
Acronym
Efficacy of Abdominal peripheral nerve block for surgical space condition
Scientific Title
Efficacy of Abdominal peripheral nerve block for Surgical space condition during robotic assisted laparoscopic surgery
Scientific Title:Acronym
Efficacy of Abdominal peripheral nerve block for surgical space condition
Region
| Japan |
Condition
Condition
Prostate cancer, Bladder cancer
Classification by specialty
| Urology | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether to improve surgical space condition with abdominal peripheral nerve block
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in depth of the abdominal cavity
Key secondary outcomes
Surgeon's evaluation for surgical space condition
Objective Evaluation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Only total intravenous anesthesia (Control Group)
Interventions/Control_2
Added to peripheral nerve block by local anesthetics(Bock Group)
Peripheral nerve block is performed only one time after induction.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)ASA 1-2
2)Elective robotic assisted laparoscopic surgery
Key exclusion criteria
1)Known allergy to local anesthetics
2)Known allergy to neuromuscular relaxant or neuromuscular antagonist
3)Liver and renal imparement
4)Difficulty of peripheral nerve block performance
5)BMI >= 30
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Satoko |
| Middle name | |
| Last name | Noguchi |
Organization
Hirosaki University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
036-8562
Address
5 Zaifu-cho, Hirosaki, Aomori
TEL
0172-39-5113
satko1110@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Satoko |
| Middle name | |
| Last name | Noguchi |
Organization
Hirosaki University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
036-8562
Address
5 Zaifu-cho, Hirosaki, Aomori
TEL
0172-39-5113
Homepage URL
satko1110@yahoo.co.jp
Sponsor or person
Institute
Hirosaki University Hospital of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hirosaki University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hirosaki University Hospital of Medicine
Address
53 Hon-cho, Hirosaki, Aomori
Tel
0172-39-5295
cksenta@hirosaki-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
30
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2016 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 14 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 15 | Day |
Last modified on
| 2019 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028586
